Continued Safety Monitoring of Solanezumab in Alzheimer's Disease (EXPEDITION EXT)

This study has been terminated.

(Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.)

Sponsor:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT01127633

First Posted: May 21, 2010

Last Update Posted: March 8, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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400 mg administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.

Other Name: LY2062430

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks

Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study

Must have good vein access to administer infusions

Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127633

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.